Class Class II

Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology (K250669)

K250669 2025-04-22 Traditional
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Description

Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology by Medtronic Sofamor Danek USA, Inc., an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250669
Clearance Date2025-04-22
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080

Categories

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Predicate lineage for K250669

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology (K250669) cites 3 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine2022
K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent ...Nu Vasive, Incorporated2021
K201267Adaptix Interbody System with Titan nanoLOCK Surface Techno...Medtronic Sofamor Danek2020

Later devices that cite this one as their predicate

Devices that cite K250669
K numberDeviceApplicantYear
K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Cat...Convatec2025

Trace the full predicate network for K250669

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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